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Tag: biotechnology


Cell and Gene Therapy, Industry

BioCina and NovaCina to Partner on Drug Substance and Product Solutions for Biologics

March 1, 2024

Via: Biopharm International

BioCina, a biologics contract development and manufacturing organization (CDMO) and NovaCina, a global fill-and-finish CDMO, have announced a partnership to offer integrated drug substance and drug product solutions for biologics developers. This will allow BioCina to provide fill/finish services while […]


News

Ensuring Contractors Perform Good Distribution Practices

March 1, 2024

Via: Biopharm International

The number of contractors and subcontractors involved in the supply chain for finished goods can be high, and their relationships very complex, particularly when goods are shipped by air or sea. Depending on the scope of the activity (e.g., whether […]


News

Can a Moderna co-founder change the CRO game?

February 29, 2024

Via: Biopharma Dive

When you’re looking to make changes to how clinical trials are run, it’s helpful to work with one of the top minds in the industry. By welcoming Robert Langer to its advisory board, that’s exactly what Lindus Health hopes to […]


Cell and Gene Therapy, Industry

Cure Ventures backs a cell therapy startup targeting Parkinson’s

February 29, 2024

Via: Biopharma Dive

Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders. Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round […]


News

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

February 28, 2024

Via: PMLiVE

The antibiotic combination has been approved for adults with cUTIs, including the kidney infection pyelonephritis, which is most commonly caused by gram-negative bacteria. UTIs are a common infection and typically require antibiotics for treatment. Accounting for approximately 19% of all […]


FDA, Regulations

Say Goodbye to PFAS Chemicals in Food Packaging: FDA

February 28, 2024

Via: Drugs.com

PFAS “forever” chemicals, increasingly linked to health risks, will no longer be added to food packaging handled by American consumers, the U.S. Food and Drug Administration announced Wednesday. “Grease-proofing materials containing per- and polyfluoroalkyl substances [PFAS] are no longer being […]


Cell and Gene Therapy, Industry

Bayer receives U.S. FDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer harboring HER2 activating mutations

February 27, 2024

Via: World Pharma News

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, […]


FDA, Regulations

Minerva schizophrenia drug rejected by FDA

February 27, 2024

Via: Biopharma Dive

The FDA’s decision sets back many years of effort by Minerva to secure approval of its drug for schizophrenia, called roluperidone and designed to treat so-called negative symptoms of the condition. The company, which licensed rights to roluperidone from Mitsubishi […]


News

UK biotech Curve swings £40.5m in Pfizer-backed round

February 27, 2024

Via: Pharmaphorum

The round was led by Pfizer’s investment arm Pfizer Ventures, with Columbus Venture Partners and British Patient Capital joining the round along with prior investors Advent Life Sciences and Epidarex Capita. The proceeds will be used to develop Curve’s Microcycle […]


FDA, Regulations

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

February 26, 2024

Via: PMLiVE

Simlandi has been approved by the regulator to treat rheumatoid arthritis, idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Biosimilars, according to the FDA, are biological products that are highly similar to […]


News

NGM to go private through deal with investment firm

February 26, 2024

Via: Biopharma Dive

Founded in 2007, NGM took a broad approach to its drug research, assembling a pipeline that spans from solid tumors to retinal diseases to liver and metabolic disorders. NGM raised a few hundred million dollars in private funding before going […]


Cell and Gene Therapy, Industry

BioMarin preaches patience amid slow sales for hemophilia gene therapy

February 23, 2024

Via: Biopharma Dive

Roctavian’s approval was a scientific milestone, the culmination of years of research developing a genetic medicine for the chronic blood disease hemophilia A. Its launch, which began in Europe in 2022 and the U.S. last year, has been a focus […]


Cell and Gene Therapy, Industry

Johnson & Johnson’s Tecvayli receives FDA approval for reduced dosing in multiple myeloma patients

February 23, 2024

Via: PMLiVE

The regulator’s decision means that RRMM patients who have achieved a complete response or better for at least six months can receive a 1.5mg/kg dose of the BCMA-targeting bispecific antibody every two weeks. More than 35,000 new cases of multiple […]


FDA, Regulations

United sues FDA to try to block rival’s drug application

February 22, 2024

Via: Pharmaphorum

In an unusual move, United Therapeutics has filed a lawsuit against the FDA which claims the regulator is sidestepping established norms in allowing rival Liquidia to file for approval of a competitor to its Tyvaso product. The suit claims that […]


FDA, Regulations

FDA’s Drug Safety Priorities for 2023

February 21, 2024

Via: Biopharm International

On Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the […]


Cell and Gene Therapy, Industry

NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

February 21, 2024

Via: Biopharma Dive

A new research paper offers the most thorough look yet at a study that sparked the drug industry’s recent experimentation with cell therapy for autoimmune diseases. The paper, which was published in The New England Journal of Medicine on Wednesday, […]


FDA, Regulations

RAPT hit by FDA clinical hold on eczema, asthma drug

February 21, 2024

Via: Pharmaphorum

The stock plunged almost 74% after the announcement of a “serious adverse event” – a case of liver failure – in the trial involving patients with atopic dermatitis, also known as eczema. RAPT said the FDA had “verbally notified” it […]


Clinical Trials, Research and Development

FDA puts hold on Rapt trials of drug for eczema, asthma

February 20, 2024

Via: Biopharma Dive

Analysts have followed Rapt as they view its drug, an oral pill dubbed zelnecirnon, as a possible competitor to Dupixent in conditions like eczema. Dupixent, which was developed by Sanofi and Regeneron, is a multibillion-dollar product approved for a range […]


Cell and Gene Therapy, Industry

AstraZeneca gets new Tagrisso OK as drug succeeds in another trial

February 20, 2024

Via: Biopharma Dive

Tagrisso is at the center of AstraZeneca’s oncology resurgence. The drug, which first won approval in the U.S. in 2015, is the company’s second highest selling product, after the diabetes and kidney disease treatment Farxiga. It has become a go-to […]


Cell and Gene Therapy, Industry

FDA Approves Amtagvi, First Cell Therapy for Skin Cancer

February 20, 2024

Via: Biopharm International

On Feb. 16, 2024, FDA announced the approval of Iovance Biotherapeutics’ Amtagvi (lifileucel), which the agency said in a press release is the first cellular therapy indicated for treating adult patients with unresectable or metastatic melanoma that has been previously […]